Instructions for Festal Neo 10000 enteric-coated tablets blister No. 20
Composition
active ingredient: pancreatin;
1 tablet contains pancreatin, which corresponds to the minimum enzymatic activity:
10,000 lipolytic IU, 7,500 amylolytic IU, 375 proteolytic IU;
excipients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, crospovidone, hypromellose, colloidal anhydrous silicon dioxide, magnesium stearate;
shell: polyethylene glycol, dry mixture "Acryl-eze white" containing talc, titanium dioxide (E 171), methacrylate copolymer, sodium lauryl sulfate, sodium carbonate, colloidal anhydrous silicon dioxide.
Dosage form
The film-coated tablets are enteric-coated.
Main physicochemical properties: film-coated tablets, round, with a biconvex surface, white or almost white in color, with a faint specific odor. Two layers are visible on the cross section.
Pharmacotherapeutic group
Digestive aids, including enzymes. Polyenzyme preparations.
Code ATXA09A A02.
Pharmacological properties
Pharmacodynamics.
Pancreatin is a pancreatic enzyme that promotes digestion. The preparation contains the main pancreatic digestive enzymes: lipase, α-amylase, proteases (trypsin and chymotrypsin), which have lipolytic, amylolytic and proteolytic effects, enhance the breakdown of proteins, carbohydrates and fats in the duodenum, the proximal part of the small intestine, which contributes to their more complete absorption. The decisive factor is the enzymatic activity of lipase, as well as the content of trypsin.
Pharmacokinetics.
The coating covering the tablets does not dissolve under the action of gastric juice and protects the enzymes from their inactivation by gastric juice. Only under the action of the neutral or slightly alkaline environment of the small intestine does the coating dissolve and the enzymes are released.
Indication
Diseases that are accompanied by disturbances in the process of food digestion due to insufficient secretion of digestive enzymes by the pancreas, such as chronic pancreatitis.
Conditions after simultaneous resection of the stomach and small intestine, conditions after pancreatectomy.
Functional acceleration of the passage of food through the intestines.
Flatulence, dyspepsia, intestinal disorders.
Preparation for X-ray or ultrasound diagnostic examinations of the abdominal organs (intestinal degassing).
To improve digestion in individuals with normal gastrointestinal function, with chewing function disorders, when consuming difficult-to-digest plant, fatty or unusual foods, or consuming excessive amounts of food.
Contraindication
Hypersensitivity to porcine pancreatin or to any of the excipients of the drug. Acute pancreatitis or chronic pancreatitis in the acute stage, acute hepatitis, mechanical jaundice. The drug should not be used in patients with obstructive intestinal obstruction.
Interaction with other medicinal products and other types of interactions
When using drugs containing pancreatin, the absorption of folic acid may decrease, which may require its additional intake into the body. With prolonged use of pancreatin, the absorption of iron may decrease.
Cimetidine may enhance the effect of the drug.
Pancreatin may reduce the effect of the hypoglycemic oral antidiabetic drugs acarbose and miglitol, so they should not be used simultaneously.
When used simultaneously with antacids containing calcium carbonate and/or magnesium hydroxide, with tannin, and alcohol-containing agents, the effectiveness of pancreatin is reduced.
Application features
The drug is contraindicated for use in acute pancreatitis or chronic pancreatitis in the acute stage. During the recovery period or when expanding the diet, the drug can be taken only as prescribed by a doctor.
In case of unusual abdominal discomfort or changes in symptoms, it is recommended to undergo an examination to exclude intestinal damage as a precautionary measure, especially if the patient uses a dose of more than 10,000 IU of EF lipase per kilogram of body weight per day.
To avoid the formation of uric acid stones, the uric acid content in the urine should be monitored.
Cases of narrowing of the colon (fibrosing colonopathy), intestinal obstruction and constipation have been reported in patients taking pancreatin in high doses or for long periods of time. Therefore, patients are advised to consult their doctor in case of persistent or worsening complaints or the appearance of any new symptoms.
The tablets should not be chewed or crushed, as this may cause early release of enzymes, which may lead to irritation of the oral mucosa and/or a decrease in enzyme activity. The drug should not be used in patients with rare hereditary forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.
The drug contains purines, so it should be used with caution in patients with the following conditions:
- gout;
- hyperuricemia;
- renal failure.
Use during pregnancy or breastfeeding
The safety of pancreatin in pregnant women has not been established. Therefore, the use of Festal NEO 10,000 during pregnancy should be avoided.
The safety of pancreatin in breastfeeding women has not been established, so the drug should be avoided during breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
There are no reservations.
Method of administration and doses
The dose of Festal NEO 10,000 depends on the deficiency of pancreatic enzymes in the duodenum and is set individually. If there are no other recommendations and in case of eating hard-to-digest plant foods, fatty or unusual foods, take 1–2 tablets at a time. In other cases, if digestive disorders occur, the recommended single dose is 2–4 tablets. If necessary, the dose of the drug can be increased. Increasing the dose to reduce the symptoms of the disease, for example, steatorrhea or symptoms of chronic pancreatitis, should be carried out only under the supervision of a doctor. The daily dose of lipase should not exceed 15,000–20,000 IU of EF per 1 kg of body weight.
Take the tablets during meals, swallowing them whole and drinking plenty of liquid, such as a glass of water.
The duration of treatment depends on the course of the disease and is determined by the doctor on an individual basis.
Children.
Use in children over 3 years of age. The doctor decides the dosage and duration of treatment for children. The drug is prescribed in a daily dose necessary to normalize bowel movements, during each main meal, but not more than 1500 U of lipase per 1 kg of body weight of a child under 12 years of age. For children over 12 years of age, the daily dose of enzymes should not exceed 15,000–20,000 U of lipase EF per 1 kg of body weight.
Overdose
Possible enhancement of side effects. Hyperuricemia and hyperuricosuria have been observed when taking extremely high doses of other pancreatic powder preparations, and constipation in children. Treatment is symptomatic: drug withdrawal, adequate hydration.
Adverse reactions
The following classification is used to estimate the frequency of side effects: very common: ≥ 1/10; common: ≥ 1/100 and < 1/10; uncommon: ≥ 1/1000 and < 1/100; rare: ≥ 1/10000 and < 1/1000; very rare: < 1/10000; frequency unknown (cannot be estimated from the available data).
From the cardiovascular system.
Frequency unknown: tachycardia.
From the immune system.
Very rare: immediate allergic reactions (skin rash, urticaria, sneezing, lacrimation, bronchospasm, dyspnea).
Frequency unknown: anaphylactic reactions, including urticaria and angioedema.
From the digestive tract.
Very rare: allergic reactions from the digestive tract (diarrhea, abdominal pain, nausea, change in the nature of stools). There may be a feeling of discomfort in the epigastric region of the stomach, flatulence, intestinal colic, intestinal obstruction.
Frequency unknown: Cases of intestinal obstruction and constipation have been reported, especially with high doses of pancreatin enzymes. Formation of strictures in the ileocecal region and in the ascending colon has been described after administration of pancreatic powder in high doses. Vomiting, irritation of the oral mucosa. Abdominal pain, diarrhea, irritation around the anus, constipation, extensive intestinal stenosis, fibrosing colonopathy.
From the side of metabolism and nutrition.
Frequency unknown: hyperuricemia.
The use of very high doses of the drug may lead to an increase in uric acid levels in the blood.
From the skin.
Frequency unknown: hyperemia, itching.
From the genitourinary system.
Frequency unknown: hyperuricosuria, especially when using high doses of the drug. Increased urinary excretion of uric acid is possible, especially when using high doses of the drug. To avoid the formation of uric acid stones in such patients, the content of uric acid in the urine should be monitored.
General violations.
Frequency unknown: feeling hot, general weakness.
Reporting of suspected adverse reactions
It is very important to report suspected adverse reactions that have occurred since the registration of the drug, as this allows for continuous monitoring of the benefit/risk balance of the use of this medicine. Healthcare professionals are encouraged to report any suspected adverse reactions through the national pharmacovigilance system.
Expiration date
2 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 ºС.
Keep out of reach of children.
Packaging
No. 20 (20 × 1): 20 tablets in a blister, 1 blister in a cardboard box.
Vacation category
Without a prescription.
Producer
LLC "Pharmex Group".
Location of the manufacturer and address of its place of business.
Ukraine, 08301, Kyiv region, Boryspil city, Shevchenko street, building 100.
Opela Healthcare Ukraine LLC, Ukraine.
Location of the applicant and address of the place of business.
Ukraine, 01033, Kyiv, Zhylyanska St., 48-50A.
